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(Senior) Regulatory Affairs Associate - Labelling & Artwork

Poland, Remote Additional Locations: ; ; ; ; ; ; ; ; ; ; 职位编号 R0000031247 类别 Consulting
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Are you passionate about regulatory affairs and project management in the pharmaceutical industry? Do you have a keen eye for detail and a talent for strategic planning? Parexel is seeking a dynamic Regulatory Affairs Associate to join our Labelling & Artwork team!

This role can be home or office based in various locations - Poland, Romania, Serbia, Czechia, Hungary and Lithuania.

About the Role: As a Regulatory Affairs Associate focusing on Secondary Packaging & Artwork, you will play a crucial role in ensuring our clients' products meet regulatory requirements and market standards. You will be responsible for developing and implementing artwork strategies, managing global product portfolios, and serving as a key liaison between various stakeholders.

Key Responsibilities:

  • Develop and oversee secondary packaging and artwork strategies for assigned product portfolios

  • Generate and maintain global product portfolio plans, including capacity and budget requirements

  • Act as a regulatory expert and ambassador for artwork implementation

  • Collaborate with cross-functional teams, including Regulatory Affairs, Supply Chain, and Technical Operations

  • Drive continuous improvement in processes and tools related to secondary packaging and artwork

  • Ensure compliance with regulatory requirements and internal processes

  • Manage change controls, deviations, and investigations related to packaging and artwork

  • Provide training and support to staff on artwork strategy and processes

Skills and Qualifications:

  • University degree in a Scientific or Technical Discipline

  • Few years of experience in a related pharmaceutical industry role

  • Strong knowledge of regulatory affairs, particularly in packaging and labeling

  • Excellent project management skills

  • Proficiency in local language and extensive working knowledge of English

  • Outstanding interpersonal and communication skills

  • Ability to work effectively in a team environment and independently

  • Strong problem-solving and critical thinking skills

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